general anaesthesia narcose sleep medication
Conditions
Interventions
After application of standard non-invasive cardiopulmonary monitoring, a
peripheral intravenous line will be inserted. Subsequently, a radial artery
catheter will be placed under local anesthesia fo
Sponsors
Universitair Medisch Centrum Groningen
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - American Society of Anesthesiologists (ASA) Physical Status I or II - No exclusion criterion is present - Informed, and willing to give written informed consent.
Exclusion criteria
Exclusion criteria: - Refusal of the volunteer to participate - Pregnancy - Diseases involving the cardiovascular system (hypertension, coronary artery disease, prior acute myocardial infarction, any valvular and/or myocardial disease involving decrease in ejection fraction, arrhythmias, which are either symptomatic or require continuous medication/pacemaker/automatic internal cardioverter defibrillator) - A difference > 15 mmHg in measured systolic or diastolic blood pressure value (SBP, DBP) between the left and right upper arm, as determined by non-invasive cuff oscillometry during the screening visit. - An increased risk of difficult mask ventilation or tracheal intubation, as judged by the anesthesiologist-researcher. - Pulmonary disease - Gastric or endocrinologic diseases - End-stage liver or kidney failure - Use of tricyclic antidepressive medication or MAO inhibitors.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - The relationship between plasma concentrations of norepinephrine and hemodynamics in terms of heart rate, cardiac index (CI), stroke volume index (SVI), and systolic, diastolic and mean arterial blood pressure (SAP, DAP, MAP, respectively) in awake circumstances. - The relationship between plasma concentrations of norepinephrine and hemodynamics in terms of heart rate, cardiac index (CI), stroke volume index (SVI), and systolic, diastolic and mean arterial blood pressure (SAP, DAP, MAP, respectively) during standardized general anesthesia using propofol and remifentanil administration. - The hemodynamic effects will be related to drug concentrations using PKPD analysis / modelling. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Evaluation of the effect of the interaction between propofol, remifentanil and norepinephrine on hemodynamics during the induction of general anesthesia. - Evaluation of the effect(s) of endogenous norepinephrine plasma concentration and observed arousal on the relationship between administered dose (and plasma concentration) of norepinephrine and induced hemodynamic alteration(s). - Internal validation of the Beloeil norepinephrine TCI PKPD model and acquisition of data in order to improve this model performance. - Assessment of changes in mean systemic filling pressure prior to and after induction of general anesthesia, as assessed by arm stop-flow measurements by application of a rapidly inflated tourniquet. - Evaluation of the dose-dependent effect of administered norepinephrine on plasma melatonin concentrations prior to and after induction of general anaesthesia. - As a post-hoc exploratory analysis, mathematical indices reflecting the complex changes in raw EEG will be investigated to assess the effects of norepinephrine on consciousness. | — |
Countries
Netherlands
Outcome results
None listed